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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069270 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
Patients with CR after completion of neoadjuvant temozolomide undergo observation.
Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-RT temozolomide, RT plus temozolomide | Experimental | Pre-radiation therapy (RT) temozolomide, RT plus temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug |
| ||
| neoadjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) | From start of treatment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From registration to date of death or last follow-up |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma
No equivocal oligodendroglial element
No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
No spinal cord tumors
No evidence of spinal drop metastasis or spread to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Vogelbaum, MD, PhD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Foundation for Cancer Research and Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18779504 | Result | Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta M. Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol. 2009 Apr;11(2):167-75. doi: 10.1215/15228517-2008-073. Epub 2008 Sep 8. | |
| Result | Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas: relationship between 1p/19q status and progression-free survival. [Abstract] J Clin Oncol 24 (Suppl 18): A-1517, 2006. | ||
| Result | Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1520, 119s, 2005. |
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| Procedure |
|
| radiation therapy | Radiation |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States |
| Shands Cancer Center at the University of Florida Health Science Center | Gainesville | Florida | 32610-0385 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| University of Miami Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33256-2110 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska | 68114-4199 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Wayne Memorial Hospital, Inc. | Goldsboro | North Carolina | 27533 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139-0000 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Akron City Hospital | Akron | Ohio | 44304 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Mount Carmel West Hospital | Columbus | Ohio | 43222 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750-1635 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055-2899 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| Anderson Area Cancer Center | Anderson | South Carolina | 29621-5705 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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